7 Questions + 7 Answers = A Brief Guide to an Effective Literature Monitoring System

As we reached the end of our series on questions and GVP references to build and effective literature system, we would like to provide an overview of the topics we touched upon in the last few weeks as a guide to the 7 steps to be successful in literature monitoring:

Firstly, we posted about WHERE to search for PV data. The common audit question we discussed in relation to that was: What’s your process for duplicate search? Follow the link for more details: https://comfiteurope.eu/literature-search-pv-data/

Second came WHAT to search FOR in literature. The related audit questions discussed were: What safety data are you searching for in literature? and What’s your indexing method? Or search terms? Find out details here: https://comfiteurope.eu/search-literature-terms-pharmacovigilance/

The third step would be to find out WHICH journals are RELEVANT to monitor. Here we answered to What is a “relevant” source? and Why is a journal out or in the monitored list?: https://comfiteurope.eu/journals-relevant-monitor-pharmacovigilance/

Next we looked at HOW to prove WHICH drugs have been monitored in a given period of time, providing strategies how to answer to challenges such as When and how did you communicate it to the service provider? and How can you prove that the service provider started monitoring?: https://comfiteurope.eu/prove-drugs-monitored-given-period-time/

Then we touched upon HOW to DOCUMENT successfully the literature monitoring activities. Here the most important audit questions to answer are What data are backed up? How often is back-up of critical data done?, Are records probably discarded according to retention rules when no longer needed for business, regulatory or other legal purposes?, How do you control access to archives? How is access authorised?, Are back-up servers located at a different location than the working servers? The details here: https://comfiteurope.eu/document-successfully-literature-monitoring-activities/

Strict timing is crucial in pharmacovigilance. Thus, the sixth step is to find out WHEN to carry out literature monitoring. In relation to that at audits one can be usually asked How can you check whether reviewing meets the timelines as outlined in the agreement? Find out our experience here: https://comfiteurope.eu/carry-literature-monitoring/

The last step we discussed was HOW to successfully SEARCH for PV data without missing anything. The challenges you would often face are: How do you make sure that indexes of the database match the Clients’ search terms, so there will be no loss? and How can you make sure that the medicinal products are indeed the ones specified in the agreement? For details go to: https://comfiteurope.eu/successfully-search-pv-data-without-missing-anything/

We believe that being able to answer to these 7 steps and challenges can form the basis of an effective, audit-proof literature monitoring system. Keep following our feed, as we will continue sharing with you our audit learnings and how we have answered well to common audit questions through our practice!